Eurasian Product Certification Introduction

Medicine

In accordance with Russian Federal Law (Pharmaceutical Distribution Act: #61-FZ / 2010.04.12), all pharmaceuticals and medical substances imported into the Russian Federation must obtain an import license and are subject to federal state control over the distribution of pharmaceuticals. State control bodies are territorial authorities under the Health Supervisory Service of the Russian Federation (ROSZDRAVNADZOR) and constituent bodies of the Russian Federation. The purpose of state supervision is to prevent, detect and contain violations of the requirements of the legislation of the Russian Federation in the field of drug distribution.

The need to comply with the Drug Distribution Act (#61-FZ)

According to the current law, violations of the law on the distribution of drugs are subject to penalties under the laws of the Russian Federation.

The relevant laws are :

✤ Resolution of the Government of the Russian Federation Article 5.1.4
Health monitoring service (No323, 2004/06/30). State oversight includes the organization and conduct of inspections for compliance with the circulation of pharmaceuticals with requirements for the distribution, transportation, dispensing, sale of pharmaceuticals, and use of pharmaceuticals.

✤ Federal Law Regulations (#294-F3, 2008/12/26)
It is about the protection of the rights of corporations and private companies in the implementation of state control (supervision) and local governments. Monitoring the integrity and quality of state supervision includes conducting inspections, identifying and eliminating violations of the applicant's rights, violating essential requirements, applying measures to contain the violation, and eliminating the consequences of such violations, reviewing, making decisions and preparing responses to the applicant's appeal.

Therefore, if your company wants to distribute medicines in Russia, you must comply with the Drug Distribution Act and other relevant laws.
Product license registration

In order to register an import license, product registration must be preceded to the Russian Federation Health Supervisory Service (ROSZDRAVNADZOR). Product registration requires registration review and clinical trials conducted by the Federal Health Supervisory Service. The registration review is determined within the 210-day period excluding the clinical trial period, and document review, production process review, and sampling type test are required.

In the case of clinical trials, the requirements for preclinical and clinical trials established by federal law of drug distribution and other regulatory laws of Russia must be complied. In accordance with Article 4, Paragraph 40 of the Drug Distribution Act (#61-FZ/2010.04.12), preclinical testing is defined as biological, microbiological, immunological, toxicological, physical testing, and stability testing of pharmaceuticals by other scientific evaluation methods. For clinical trials, this includes research into the diagnosis, treatment, prevention and pharmacological properties of a drug.

This includes interactions with other pharmaceuticals and foods, not limited to processes such as absorption, allocation and transformation by scientific methods.
Application for import permit

After the drug is registered with the Federal Health Supervisory Service, you can apply for an import license, and all drug certifications that are initially registered are valid for five years. After that, upon renewal, the certificate of the approved drug is indefinitely valid.

In addition to issuing a drug registration certificate, it is also necessary to obtain a Certificate of Conformity or a Declaration of Conformity according to Russian certification GOST R.
Products subject to certification

According to the legislation of the Russian Federation government (#982, 2009.12.01), the items that require certification are immunoglobulins, gamma globulin, serum, toxins, medical and veterinary vaccines. Items subject to the declaration of conformity include drugs, pharmaceutical chemicals, coenzymes, enzymes, amino acids, vitamins, organic products, and veterinary serum.
Benefits of pharmaceutical certification : prospects of expanding Eurasian pharmaceutical certification

Eurasian countries that require drug certification are expected to increase further. Currently, the member countries of the Eurasian Economic Union are in the process of forming a pharmaceutical market community as in the case of medical devices.
- On December 23, 2014, Russia, Belarus and Kazakhstan signed an agreement on common rules and principles for drug distribution within the EEC.
- And applied about 26 regulations including No. 78 Drug Registration Inspection Regulation (November 3, 2016) (Applicable date: 2017.05~)
Therefore, the effectiveness and application of drug certification will be expanded.
EAEU drug distribution regulation

On May 5, 2017, the Eurasian Economic Commission announced that the 26-document EAEU drug distribution regulation came into effect on May 6, 2017. Transnational regulations apply to drug development, preclinical and clinical research, quality control, registration, production and distribution, while national regulations include preclinical and clinical trials, pricing, retail, public procurement, cost reimbursement, and advertising.

There is a grace period until December 31, 2020, so if you need a registration certificate, you can choose between EAEU and national regulatory systems to apply. If applying for registration before December 31, 2018, EAEU manufacturers were required to submit according to the country-specific regulatory system instead of the EAEU GMP certificate. All drugs registered in accordance with the regulations prior to December 31, 2020 must be re-registered in accordance with the regulations of each market by December 31, 2025.
IGC’s Competency
- IGC is providing certification services for medicines in cooperation with RUS-TEST PACIFIC, an Eurasian regional certification service provider.
- IGC auditors are contributing to the continuous development of customers by accurately evaluating the suitability through the technology and expertise accumulated over the years.
- IGC is a reliable global leader in Eurasian certification, providing certification for medical devices, cosmetics, food and EAC certification as well as pharmaceuticals.
- IGC has up-to-date knowledge of a wide range of specific scope and legal requirements in major markets around the world, and provides the knowledge and services to support your entire global operation.